• YAKHAK HOEJI
• /
• v.56 no.5
• /
• pp.288-292
• /
• 2012

The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

• Analytical Science and Technology
• /
• v.35 no.3
• /
• pp.93-115
• /
• 2022

Potential impurities in pharmaceuticals could be produced during manufacture, distribution, and storage and affect quality and safety of pharmaceuticals. In particular, highly reactive impurities could result in carcinogenic (mutagenic) effects on human body. International Conference on Harmonisation (ICH) has provided M7(R1) guideline for "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" and recommended an adoption of this guideline to the authorities. ICH M7(R1) guideline provides classification, accepted intakes, and controls of potential impurities in pharmaceuticals. However, since appropriate and unified analytical methods for impurities in pharmaceuticals have not been provided in this guideline, most potential impurities in pharmaceuticals are still difficult to manage and supervise by pharmaceutical companies and regulatory authorities, respectively. In this review, we briefly described definition of unintended mutagenic impurities, basic information in ICH M7(R1) guideline, and analytical methods to determine potential impurities. This review would be helpful to manage and supervise potential impurities in pharmaceuticals by pharmaceutical companies and regulatory authorities.

• Journal of Microbiology and Biotechnology
• /
• v.9 no.4
• /
• pp.386-392
• /
• 1999

A large-scale culture of hepatitis A virus in human diploid MRC-5 cells was conducted. In a roller bottle culture, the virus was grown to a maximum titer in 3 weeks after infection. Over 95％ of the cell-associated virus was excreted after culturing the infected cells in suspension media without fetal bovine serum for 3 days. The cultured virus was inactivated with formalin, concentrated by ultrafiltration, and partially purified by ultracentrifugation in a non-ionic gradient medium of Renocal. Two separate peak fractions showing high anti-HAY ELISA titer were pooled and about 40％ of HAV antigen was recovered by this purification procedure. Of the partially purified vaccine, the protein pattern in SDS-PAGE and immunogenicity in mice were compared with a commercial HAV vaccine. In SDS-PAGE, the purified vaccine in this study and the commercial vaccine showed almost the same protein pattern. The seroconversion rate of the purified vaccine in mice was not different from that of the commercial vaccine. Therefore, we could prepare a good grade of HAV vaccine by a simple purification procedure although the purification itself was not completed.

• Journal of Preventive Medicine and Public Health
• /
• v.41 no.2
• /
• pp.69-73
• /
• 2008

To curb a rapid increase in expenditures for pharmaceuticals, the Korean government introduced a positive list system and a negotiation process for drug prices at the end of 2006. Economic evaluation of pharmaceuticals has begun to have a pivotal role in the listing and pricing of drugs for the Korean National Health Insurance. There are some points to discuss regarding the use of economic evaluation in the listing and pricing in the context of the Korean system. First, the listing and pricing processes have been fragmented, evoking complaints from pharmaceutical companies and delaying the access of new drugs to patients. Second, there is a concern that the positive list system may limit the range and availability of drugs for patients to choose for treatment. Third, the time schedule for de-listing of existing drugs may not be realistic. Fourth, it is not always easy to provide reliable evidence of cost-effectiveness due to a lack of materials. Fifth, there is no consensus on the range of the ICER (incremental cost-effectiveness ratio) acceptable to the Korean society. In conclusion, in the near future, it will be necessary to evaluate the achievements that the economic evaluation has provided to the Korean society.

• Journal of Microbiology and Biotechnology
• /
• v.28 no.4
• /
• pp.613-621
• /
• 2018

In this study, interface-assembled carbonyl reductase (IACR) was prepared and used in the synthesis of S-licarbazepine in a toluene/Tris-HCl biphasic system. The carbonyl reductase (CR) was conjugated with polystyrene to form a surfactant-like structure at the interface of the toluene/Tris-HCl biphasic system. The interface-assembled efficiency of IACR reached 83% when the CR (180 U/mg) and polystyrene concentration were $8{\times}10^2g/ml$ and $3.75{\times}10^3g/ml$, respectively. The conversion reached 95.6% and the enantiometric excess of S-licarbazepine was 98.6% when $3.97{\times}10^6nmol/l$ oxcarbazepine was converted by IACR using 6% ethanol as a co-substrate in toluene/Tris-HCl (12.5:10) at $30^{\circ}C$ and $43{\times}g$ for 6 h. IACR could be reused efficiently five times.

• Korean Journal of Environmental Agriculture
• /
• v.30 no.1
• /
• pp.68-75
• /
• 2011

BACKGROUND: To assess and prevent the environmental impacts and risks by veterinary pharmaceuticals, Guidance on Estimating Soil Persistence and Degradation Kinetics from Environmental Fate Studies on Veterinary Pharmaceuticals for Environmental Risk Assessment was proposed. METHODS AND RESULTS: Proposed guidance was coined by VICH, EU guideline, OECD guideline and soil dissipation studies for the purpose of international harmonizing. Guidance was also modified from pesticide soil persistence testing guidelines of US, EU, and Korea, with practical approaches adopting in-use test guideline for Korea. CONCLUSION(S): Proposed guidance are consisted of three parts; Laboratory Soil Experiment, Field Soil Dissipation Study, and Estimation of $DT_{50}/DT_{90}$. Proposed guidance is to be available for the requirement for registration of veterinary pharmaceuticals with fit for purpose in Korea.

• Journal of Biomedical Engineering Research
• /
• v.31 no.2
• /
• pp.123-128
• /
• 2010

The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.14 no.11
• /
• pp.5809-5818
• /
• 2013

This study proposes a technology portfolio analysis method for technology outsourcing of pharmaceutical cooperations by applying the concepts of 'Pipeline Soundness' and 'Patent Validity'. This study also applied the developed portfolio analysis method to a 'real world case' of Amgen's acquisition of Onyx Pharmaceuticals to prove the applicability of the method to the real world cases and investigated the validity of the acquisition affair between the two companies. The results of portfolio analysis showed that Amgen's technology portfolio will be improved by acquiring Onyx Pharmaceuticals especially in cancer field which is their main field. So we concluded that Amgen's choice of Onyx pharmaceuticals as a source of technology outsourcing was reasonable. We think that the technology portfolio analysis method developed by this study will be a valuable tool for pharmaceutical cooperations for investigating their current technology status and selecting target companies for technology outsourcing.

• Journal of Environmental Analysis, Health and Toxicology
• /
• v.21 no.4
• /
• pp.243-251
• /
• 2018

Pharmaceuticals in wastewater effluents have been recognized as emerging pollutants threatening freshwater organisms. To extend understanding for bioaccumulation and toxicity in those organisms, information on biotransformation products (or metabolites) and their metabolic pathway are crucial. The aim of the present study is to identify and elucidate metabolites of pharmaceuticals formed in exposed organisms using suspect and nontarget screening approach using LC-HRMS. As the target pharmaceuticals, carbamazepine, ketoprofen, metoprolol, propranolol, and verapamil were selected whereas Daphnia magna and Gammarus pulex were used as test organisms. After 24h exposure, metabolites formed in the organisms were identified using LC-HRMS. The structures of metabolites were elucidated via analysis of MS/MS fragment pattern and the comparison with fragment database. As the results, a total of 10 metabolites were identified for 5 parent compounds (C253/C356 for carbamazepine, K211 for ketoprofen, M256 for metoprolol, P218/P276/P306 for propranolol, V196/V291/V441 for verapamil). Among them, the presence of C253 and V291 was confirmed using standard materials. Most of the identified metabolites were formed through oxidative reactions such as hydroxylation, N-demethylation, and dealkylation. Cysteine conjugation (phase II reaction) metabolite (C356) for carbamazepine was found in daphnia. The metabolic pathway of verapamil showed similar metabolic pathways and metabolic pathways for both species. Although the toxicological information on the identified metabolites could not be confirmed, the molecular structure information of the proposed metabolites can be used for future evaluation and prediction of toxicity.

• Journal of Society of Preventive Korean Medicine
• /
• v.26 no.2
• /
• pp.69-74
• /
• 2022

Objective : This study was aimed to review the Act on the Promotion of Korean Medicine and Pharmaceuticals. Method : We searched document about the Act on the Promotion of Korean Medicine and Pharmaceuticals. We used Korean Law Information Center(https://www.law.gov.kr) to find the revision of the act. Results : We looked at the current status of the revision of the Act on the Promotion of Korean Medicine and Pharmaceuticals, and the law was revised four times in total. Through the revision of the law, the definition of Korean medical practice was not only expanded, but also the establishment and role of National Institute of Korean Medicine Development were extended. Specific descriptions of Korean medicine technology will be needed in the future, and laws that are less effective should be revised and the role of National Institute of Korean Medicine Development should be further strengthened. Conclusion : For the future of Korean medicine, in-depth consideration is needed on how to foster oriental medicine.